Medical Waste Management Act 2017 - California Department Of Public Health

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Medical Waste Management Act January 2017 California Health and Safety Code Sections 117600 - 118360 California Department of Public Health Medical Waste Management Program 1616 Capitol Avenue, MS-7405 P. O. Box 997377 Sacramento, CA 95899-7377

January 2017 Medical Waste Management Act California Health and Safety Code Sections 117600 – 118360 Table of Contents CHAPTER 1 - GENERAL PROVISIONS .7 117600 - CITATION OF PART.7 117605 - PREEMPT .7 117610 - REGULATIONS .8 117615 - LOCAL ORDINANCE .8 CHAPTER 2 - DEFINITIONS .8 117625 - DEFINITIONS .8 117630 - BIOHAZARD BAG .8 117636 - CHEMOTHERAPEUTIC AGENT .9 117637 - COMMON CARRIER .9 117640 - COMMON STORAGE FACILITY .9 117645 - CONTAINER .9 117647 - EMPTY .9 117650 - ENFORCEMENT AGENCY .9 117655 - ENFORCEMENT OFFICER .10 117657 - FUND .10 117660 - HAZARDOUS WASTE HAULER .10 117662 - HEALTH CARE PROFESSIONAL .10 117665 - HIGHLY COMMUNICABLE DISEASES .10 117670 - HOUSEHOLD WASTE .10 117671 - HOME-GENERATED SHARPS W ASTE .10 117672 - INDUSTRIAL HYGIENIST .10 117675 - INFECTIOUS AGENT .11 117680 - LARGE QUANTITY GENERATOR .11 117685 - LOCAL AGENCY .11 117690 - MEDICAL W ASTE.11 117695 - TREATED MEDICAL W ASTE .13 117700 - NOT MEDICAL WASTE .13 117705 - MEDICAL W ASTE GENERATOR .14 117710 - MEDICAL W ASTE MANAGEMENT PLAN .14 117715 - MEDICAL W ASTE PERMIT.14 117720 - MEDICAL W ASTE REGISTRATION .14 117725 - MEDICAL W ASTE TREATMENT FACILITY .15 117730 - MIXED W ASTE .15 117735 - OFFSITE .15 117740 - ONSITE .15 2

January 2017 117742 - PARENT ORGANIZATION .15 117745 - PERSON .15 117747 - PHARMACEUTICAL .16 117750 - SHARPS CONTAINER .16 117760 - SMALL QUANTITY GENERATOR.16 117765 - STORAGE .16 117770 - TRACKING DOCUMENT.16 117771 - SHIPPING DOCUMENT .16 117775 - TRANSFER STATION .17 117776 - TRAUMA SCENE .17 117778 - TRAUMA SCENE W ASTE MANAGEMENT PRACTITIONER .17 117780 - TREATMENT.17 CHAPTER 3 - POWERS AND DUTIES .17 117800 - LOCAL AGENCY .17 117805 - NOTIFY DEPARTMENT.17 117810 - IMPLEMENTATION .17 117815 - PROGRAM CONSISTENCY .18 117820 - MEDICAL W ASTE MANAGEMENT PROGRAM .18 117825 - REGISTRATION AND PERMIT FEES .18 117830 - ENFORCEMENT AGENCY .19 117835 - DEPARTMENT’S DATABASE .19 117840 - INTENT OF THE LEGISLATURE .19 117845 - DEPARTMENT SHALL IMPLEMENT .19 117850 - SHARE INFORMATION .19 117855 - W ITHDRAWAL .19 117860 - DEPARTMENT BECOMES ENFORCEMENT AGENCY .19 117870 - DEPARTMENT IDENTIFIES SIGNIFICANT VIOLATIONS .19 117875 - W ITHDRAWAL .20 117880 - FEES .20 117885 - FUND .20 117890 - LARGE QUANTITY GENERATOR (LQG) REGISTRATION .20 117895 - SMALL QUANTITY GENERATOR (SQG) REGISTRATION .20 117900 - MEDICAL W ASTE HAULER REGISTRATION .20 117903 - TREAT MEDICAL W ASTE .21 117904 - CONSOLIDATION .21 117905 - OFFSITE TREATMENT .22 117908 - COMMON STORAGE FACILITY .22 117910 - TECHNICAL ASSISTANCE & GUIDANCE .22 CHAPTER 4 - SMALL QUANTITY GENERATOR REQUIREMENTS .22 117915 - CONTAINMENT AND STORAGE .22 117918 - TREATMENT.22 117920 - REGISTRATION.22 117923 - FEES .23 117924 - COLLECT FEES .23 117925 - ONSITE TREATMENT .24 3

January 2017 117928 - COMMON STORAGE FACILITY .24 117930 - TREAT ONSITE .25 117935 - MEDICAL W ASTE MANAGEMENT PLAN .25 117938 - BIENNIAL INSPECTION .26 117940 - MEDICAL W ASTE GENERATOR REGISTRATION .26 117943 - TREATMENT AND TRACKING RECORDS .26 117945 - INFORMATION DOCUMENTATION AND TRANSPORTATION RECORDS .27 117946 - MATERIALS OF TRADE EXEMPTION .27 CHAPTER 5 - LARGE QUANTITY GENERATOR REQUIREMENTS .28 117950 - REGISTRATION.28 117960 - MEDICAL W ASTE MANAGEMENT PLAN .28 117965 - ANNUAL INSPECTION .29 117967 - ONSITE TREATMENT .29 117970 - MEDICAL W ASTE GENERATOR REGISTRATION .29 117971 - INSPECTION AND ENFORCEMENT COST RECOVERY.30 117975 - TREATMENT AND TRACKING RECORDS .30 117976 - MATERIALS OF TRADE EXEMPTION .30 117980 - CONTAINMENT AND STORAGE .31 117985 - TREATMENT.31 117990 - FEES .31 117995 - COLLECT FEES .31 CHAPTER 6 - MEDICAL WASTE HAULERS .32 118000 - TRANSPORTATION OF MEDICAL W ASTE.32 118025 - REGISTRATION.33 118027 - UNKNOWINGLY TRANSPORTS .33 118029 - INFORMATION REQUIREMENTS .33 118032 - PHARMACEUTICAL W ASTE HAULING EXEMPTION .34 118033 - SECURE PHARMACEUTICAL W ASTE .35 118035 - TRANSFER OF MEDICAL W ASTE .35 118040 - TRACKING RECORDS .36 118045 - TRANSFER STATION PERMIT .36 CHAPTER 7 - MEDICAL WASTE TREATMENT FACILITY PERMITS .37 118130 - PERMITS .37 118135 - PERMIT PRIOR TO OPERATION .37 118140 - ACCEPTING MEDICAL W ASTE .37 118145 - ADJACENT SMALL QUANTITY GENERATORS .37 118147 - CONSOLIDATION .37 118150 - COMPLIANCE .38 118155 - PERMITS .38 118160 - PERMIT REQUIREMENTS .38 118165 - TREATMENT AND TRACKING RECORDS .39 118170 - DURATION OF PERMIT .39 118175 - CONDITIONS FOR GRANTING PERMIT .39 118180 - PERMIT VALIDITY .39 4

January 2017 118185 - PERMIT PROCEDURES .40 118190 - PERMIT CONDITIONS .40 118195 - DENIAL OF PERMIT .40 118200 - INSPECTION .40 118205 - FEES .40 118210 - COLLECT FEES .40 CHAPTER 8 - TREATMENT .41 118215 - METHODS.41 118220 - ANATOMICAL PARTS .43 118222 - W ASTE REQUIRING SPECIFIED METHODS .43 118225 - SHARPS W ASTE.43 118230 - INCINERATION .44 118235 - EMERGENCY ACTION PLAN .44 118240 - ANIMAL CARCASSES .44 118245 - FEES FOR ALTERNATIVE TREATMENT TECHNOLOGIES .44 CHAPTER 9 - CONTAINMENT AND STORAGE .44 118275 - MEDICAL W ASTE SEGREGATION AND STORAGE .44 118280 - CONTAINMENT AND STORAGE .46 118285 - SHARPS W ASTE.48 118286 - MANAGEMENT OF HOME-GENERATED SHARPS W ASTE.48 118290 - COMMON STORAGE FACILITY .48 118295 - W ASH AND DECONTAMINATE CONTAINERS .49 118300 - SPILL DECONTAMINATION .49 118305 - SOLID W ASTE .49 118307 - INTERIM STORAGE AREA .49 118310 - DESIGNATED ACCUMULATION AREA .49 118315 - TRASH CHUTES .50 118320 - COMPACTORS OR GRINDERS .50 CHAPTER 9.5 - TRAUMA SCENE WASTE MANAGEMENT .51 118321 - CITATION OF PART .51 118321.1 - REGISTRATION AND FEES .51 118321.2 - LIST OF PRACTITIONERS .51 118321.3 - DEPARTMENT DUTIES.51 118321.4 - TRANSPORTER DEEMED GENERATOR .52 118321.5 - REMOVAL, TRANSPORTATION, AND STORAGE .52 118321.6 - LIMITATIONS .52 CHAPTER 10 - ENFORCEMENT .53 118325 - INJUNCTION FOR VIOLATIONS .53 118330 - ORDER FOR COMPLIANCE / ADMINISTRATIVE PENALTY .53 118335 - INSPECTION .56 118340 - UNAUTHORIZED ACTIONS / CRIMINAL PENALTY .56 118345 - FALSE STATEMENTS / FAILURE TO REGISTER .57 CHAPTER 11 - SUSPENSION OR REVOCATION .57 5

January 2017 118350 - GROUNDS FOR SUSPENSION OR REVOCATION .57 118355 - PROCEEDINGS .58 118360 - TEMPORARY PERMIT SUSPENSION .58 6

January 2017 Chapter 1 - General Provisions 117600 - Citation of part This part shall be known and may be cited as the Medical Waste Management Act. 117605 - Preempt (a) This part governs medical waste management at the facility where waste is generated, at transfer stations, and at treatment facilities. This part also governs the tracking of medical waste beyond what is required in federal shipping documents and regulates aspects of the transport of regulated medical waste. (b) Sections 173.196 and 173.197 of Title 49 of the Code of Federal Regulations impose standards for the transportation of medical waste on public roads and highways while in transport, unless an affected person applies to, and receives a determination of any perceived conflict from, the United States Secretary of Transportation. Domestic Mail Manual 601.10.17.5 (Mailability: Hazardous Materials: Sharps and Other Mailable Regulated Medical Waste) imposes standards for the transportation of medical waste through the mail and approves medical waste mail back systems. (c) The department shall submit to the Legislature by no later than January 1, 2016, a report describing the interaction of federal and state law for the transport of regulated medical waste. The department shall convene a stakeholder group that includes, but is not limited to, small and large quantity generators, haulers, transfer station operators, treatment facility operators, local enforcement agencies, retailers, and other affected entities for this purpose. The reporting requirement imposed by this subdivision shall expire as of January 1, 2016, or when the report is submitted to the Legislature. The report submitted pursuant to this section shall be submitted in compliance with Section 9795 of the Government Code. (d) The department may, in its discretion, update standards related to the transportation of medical waste during transit through a guidance document provided to regulated entities and posted on the department’s Internet Web site. This guidance document shall be exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to the extent that the department finds that the updated standards are consistent with the standards of the United States Department of Transportation. (e) If an affected person, including the department, seeks a preemption determination pursuant to Section 5125 of Title 49 of the United States Code or by a court of competent jurisdiction, the department may, in its discretion, temporarily waive the state transportation requirements under this part until that determination is made and shall provide notice of the waiver on its Internet Web site. (f) During the period of temporary waiver described in subdivision (e), or if preemption is found, the federal requirements shall be deemed to be the law of this state and enforceable by the department. The department may enforce these federal requirements 7

January 2017 by providing an updated guidance document to interested parties and posting the updated guidance document on the department’s Internet Web site. (g) The Medical Waste Management Act does not preempt any local ordinance regulating infectious waste, as that term was defined by Section 25117.5 as it read on December 31, 1990, if the ordinance was in effect on January 1, 1990, and regulated both large and small quantity generators. Any ordinance may be amended in a manner that is consistent with this part. 117610 - Regulations The department shall adopt regulations that will establish and ensure statewide standards for uniformity in the implementation and administration of this part and that will promote waste minimization and source reduction. 117615 - Local Ordinance Notwithstanding Section 117605, with the approval of the director, and in the interest of public health, a local ordinance providing more stringent requirements than specified in this part may be implemented for a specified time period. Chapter 2 - Definitions 117625 - Definitions Unless the context requires otherwise, the definitions in this article govern the construction of this part. 117630 - Biohazard Bag (a) “Biohazard bag” means a disposable film bag used to contain medical waste. Notwithstanding subdivision (b) of Section 117605, the film bags that are used to line the United States Department of Transportation (USDOT)-approved shipping containers for transport from the generator’s facility onto roadways and into commerce to a treatment and disposal facility shall be marked and certified by the manufacturer as having passed the tests prescribed for tear resistance in the American Society for Testing Materials (ASTM) D1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and for impact resistance in ASTM D1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method,” as those documents were published on January 1, 2014. The film bag shall meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both parallel and perpendicular planes with respect to the length of the bag. (b) The biohazard bag that is used to collect medical waste within a facility shall be manufacturer certified to meet the ASTM D1709 dart drop test, provided that when the bag is prepared for transport offsite, it is placed into a USDOT-approved container lined with a biohazard bag that is ASTM D1709 and ASTM D1922 certified. (c) The color of the bag shall be red, except when yellow bags are used to further segregate trace chemotherapy waste and white bags are used to further segregate 8

January 2017 pathology waste. The biohazard bag shall be marked with the international biohazard symbol and may be labeled by reference as authorized by the USDOT. 117636 - Chemotherapeutic Agent “Chemotherapeutic agent” means an agent that kills or prevents the reproduction of malignant cells. Chemotherapeutic agent excludes anti-inflammatory and antibiotic medications used to treat malignant cells in the practice of veterinary medicine. 117637 - Common Carrier “Common carrier” means either of the following: (a) A person or company that has a United States Department of Transportation number issued by the Federal Motor Carrier Safety Administration and is registered with the Federal Motor Carrier Safety Administration as a for-hire property carrier. (b) A person or company that has a motor carrier of property permit issued by the Department of Motor Vehicles pursuant to the Motor Carriers of Property Permit Act (Division 14.85 (commencing with Section 34600) of the Vehicle Code) and, if applicable, a carrier identification number issued by the Department of the California Highway Patrol pursuant to Section 34507.5 of the Vehicle Code. 117640 - Common Storage Facility “Common storage facility” means any designated accumulation area that is onsite and is used by small quantity generators otherwise operating independently for the storage of medical waste for collection by a registered hazardous waste hauler. 117645 - Container “Container” means the rigid container in which the medical waste is placed prior to transporting for purposes of storage or treatment. 117647 - Empty “Empty” means a condition achieved when tubing, a container, or inner liner removed from a container that previously contained liquid or solid material, including, but not limited to, a chemotherapeutic agent, is considered empty. The tubing, container, or inner liner removed from the container shall be considered empty if it has been emptied so that the following conditions are met: (a) If the material that the tubing, container, or inner liner held is pourable, no material can be poured or drained from the tubing, container, or inner liner when held in any orientation, including, but not limited to, when tilted or inverted. (b) If the material that the container or inner liner held is not pourable, no material or waste remains in the container or inner liner that can feasibly be removed by scraping. 117650 - Enforcement Agency “Enforcement agency” means the department or the local agency admin

California Health and Safety Code Sections 117600 - 118360. California Department of Public Health Medical Waste Management Program 1616 Capitol Avenue, MS-7405 P. O. Box 997377 Sacramento, CA 95899-7377.

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